Incontinence device insertion kit

ABSTRACT

A kit to facilitate self-placement of an incontinence prevention device within the urethra includes a deployment base member, a deployment tube, a deployment pusher along with the incontinence prevention device in a sterile pack. The base member includes a rigid shaft of a predetermined length having a finger grip member at one end and a hook member at its opposite end. The shaft of the base member is adapted to fit through the lumen of the deployment tube with the hook projecting out from a proximal end of the deployment tube and with the hook engaging a retention loop on the incontinence prevention device when in its sterile package. Upon removal of the kit components, the deployment tube is slid off the deployment base member and, in doing so, the incontinence prevention device becomes loaded into the deployment tube. The pusher is then used to urge the incontinence prevention device from the deployment tube into the urethra.

BACKGROUND OF THE INVENTION

I. Field of the Invention

This invention relates generally to a system for treating female stressincontinence, and more particularly to a kit containing components forfacilitating placement of an incontinence prevention device in thefemale urethra.

II. Discussion of the Prior Art

In my U.S. Pat. No. 6,311,689B1, I describe an incontinence preventiondevice that comprises a soft, flexible, elastomeric shaft member,preferably silicone, that is sized to fit in the female urethra andwhich has a retention structure in the form of a closed loop at a distalend of the shaft member that is adapted to cooperate with the bladderneck to prevent the device from being expelled during voluntaryurination. The device further includes a proximal wing-like retentionstructure adapted to cooperate with the vestibule proximate the urethralmeatus to prevent upward migration.

In order to insert the incontinence prevention device, a lumen isprovided for receiving a straightening stylet therein. With the styletfully inserted, the distal retention loop is rendered generallyrectilinear so as to exhibit a low profile. The tip portion may then belubricated and the device is inserted by advancing the distal retentionstructure in its straightened condition on the stylet through theurethral meatus and up the urethra until the distal retention device isresident in the patient's bladder. At this point, the stylet is removed,allowing the loop to reform on the distal end of the shaft.

While the device and method of insertion described in the '689 patent issafe and effective, concern has been expressed by some patients aboutthe use of a stiffening stylet. Some have expressed fear that thestiffening stylet might be made to pierce through the wall defining thestylet lumen, and that it could result in injury to the urethral wall asthe incontinence prevention device is being inserted.

It is accordingly a principal object of the present invention to providea method and apparatus for inserting an incontinence prevention devicein the female urethra that does not require the use of a stiffeningstylet wire to render the device initially rectilinear for placementwithin the urethra.

It is a further object of the invention to provide an incontinenceprevention device and an insertion mechanism as a kit for use by apatient at home and without the aid of a medical professional.

SUMMARY OF THE INVENTION

The present invention provides a kit for use in treating female stressincontinence. The kit contains an incontinence prevention device havinga relatively soft, elastomeric shaft with a closed loop bladderretention structure at a distal end thereof and a vestibule engagingretention structure at its proximal end. The insertion assembly includesa deployment base member having a finger grip at a proximal end thereofand at least one rigid shaft projecting longitudinally from the fingergrip. The rigid shaft includes a device engagement element at its distalend. The kit further includes a tubular handle, referred to herein as adeployment tube, for receiving the incontinence prevention device in alumen thereof at a time immediately prior to deployment of theincontinence prevention device into the urethra. The deployment tube isslidable over the rigid shaft for facilitating loading of theincontinence device into the lumen of the deployment tube. Its diameteris such that the retention loop is collapsed and rectilinear. The kitfurther contains a plunger that is adapted to fit within the lumen ofthe deployment tube and which can be used to eject the incontinencedevice from the deployment tube into the urethra.

The incontinence device can be loaded into the deployment tube a shorttime prior to self-placement into the urethra so that the retention loopdoes not take a set, that could preclude the loop retention structurefrom opening up upon reaching its location in the bladder neck.Moreover, there is no need for the patient to touch the incontinencedevice itself, thereby maintaining a sterile condition and minimizingthe occurrence of infection.

There are, of course, additional features of the invention that will bedescribed hereinafter which will form the subject matter of the appendedclaims. Those skilled in the art will appreciate that the preferredembodiments may readily be used as a basis for designing otherstructures, methods and systems for carrying out the several purposes ofthe present invention. It is important, therefore, that the claims beregarded as including such equivalent constructions since they do notdepart from the spirit and scope of the present invention. The foregoingand other features and other advantages of the invention will beapparent from the following more particular description of preferredembodiments of the invention, as illustrated in the accompanyingdrawings.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a kit comprising the incontinence deviceand a preferred embodiment of an associated insertion assembly, allcontained within a sterile package;

FIG. 2 is a side elevation view of the deployment base member in theembodiment of FIG. 1;

FIG. 3 is a cross-sectional view taken along the line 3—3 in FIG. 2;

FIG. 4 is a perspective view of the deployment tube contained in the kitof FIG. 1;

FIG. 5 is a partial cross-sectional view of the deployment tube mountedon the deployment base member prior to use;

FIG. 6 is a perspective view of the deployment pusher;

FIG. 7 is a cross-sectioned side view of the deployment tube with thepusher member inserted fully therein; and

FIG. 8 is a perspective view of an alternative embodiment of the presentinvention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring first to FIG. 1, there is shown a component kit 10 comprisinga sterile package 12 containing an incontinence prevention device 14, adeployment base member 16, a deployment tube 18 and a pusher plunger 20.The kit may also conveniently contain a supply of a gel lubricant (notshown). Following the sealing of the kit components in the package 12,the package is subjected to a sterilization operation such as bysubjecting the package to gamma radiation in a manner well known in theart or by introducing a sterilant such as ethylene oxide into thepackage.

The incontinence prevention device 14 may be made in accordance with theteachings of my patent U.S. Pat. No. 6,311,689B1, which is herebyincorporated by reference. It need not, however, have a stylet lumentherein. The device comprises an elongated, soft, elastomeric shaft 24having an enlarged closed loop 26, also formed from a soft elastomericmaterial preferably silicone rubber, affixed to the distal end of theshaft 24. A proximal retention member 28 in the form of a wing-likeprojections, also of a soft material that is configured to conform tothe vestibule proximate the urethral opening is disposed on a proximalend of the shaft 24.

Those desiring more detailed information on the size and shapeconfiguration of the incontinence prevention device 14 may derive samefrom a reading of the aforereferenced '689 patent.

As will be explained in greater detail hereinbelow, the device 14 may beself-inserted into the urethra by a female subject by first loading thedevice 14 into the deployment tube 18 in a manner yet to be describedand then positioning the distal end of the delivery tube proximate theurethral meatus and expelling the device 14 from the deployment tube 18using the deployment plunger 20 as a pusher device.

Because the retention loop 26 of the device 14 can, with time, take on apermanent set if packaged with the device 14 already contained withinthe lumen of the deployment tube 18, it is a feature that the placementof the incontinence prevention device 14 within the deployment tube canbe achieved only a relatively short time prior to use of the deploymentdevice to insure that the retention loop 26 will fully expand to itsopen-loop shape once the loop enters the urinary bladder where it isunconstrained either by the delivery tube 18 or the urethra. It is alsoimportant to insure that the device 14 remains sterile and that it doesnot come in contact with the subject's fingers during the insertionprocess. The delivery kit 10 of the present invention assures theseresults.

Referring next to FIG. 2, there is shown a side elevation view of thedeployment base member 16 of FIG. 1. In the preferred embodiment, itcomprises a finger grip element 30 which may be somewhat semi-circularin shape and having a recessed central portion 32 defined by aperipheral wall 34. Having this shape allows the device 16 to be readilygripped between the thumb and forefinger of a user's hand.

Projecting longitudinally from a base 36 of the finger grip element 30is a longitudinally extending rod 38 having an integrally molded,L-shaped hook as a device engagement element 40 formed at the distal endthereof. In accordance with the embodiment of FIG. 2, the deploymentbase member 16 further includes a second rigid,longitudinally-extending, rail 42 that has an integrally molded stopmember 44 at its distal end. The rail 42 preferably has a somewhatI-shaped cross-section, as best seen in the cross-sectional view of FIG.3.

The length of the rail 42 is greater than that of the first rigid rod 38by a predetermined amount. Without limitation, the length of the firstrod 38 may be approximately 92.75 mm and the length of the rod 42 may be107.25 mm.

Referring now to FIG. 4, it shows a perspective view of the deploymenttube 18 of the kit 10. Tube 18 has a distal end 44 and a proximal end 46with a lumen 48 extending therebetween. Integrally formed with andprojecting perpendicularly to the longitudinal axis of the tube 18 atits distal end 44 is an insertion limit 50. The lower end of theinsertion limit member 50 includes a T-shaped notch 52. It isdimensioned to engage the guide rail 42 comprising the second rod of thedeployment base member 16 when the first rod 38 of the deployment basemember 16 is disposed within the lumen 48 of the deployment tube 18. Thelumen 48 has a shape to accept the rigid rod 38 therein with sufficientclearance to permit the tube to slide relative to the road 38. Opposedsidewall surfaces of the tube 18 may be slightly indented as at 54 andthese surfaces are preferably knurled to facilitate gripping thereof bythe user.

To facilitate entry of the retention loop 26 of the incontinence device14 into the deployment tube 18, it has been found expedient to provide aflared or oval opening on the proximal end of the deployment tube wherethe opening has a chamfered edge 49. This shape on the distal end of thedeployment tube causes the retention loop 26 to compress into twocontiguous parallel, rectilinear segments as it is being drawn by thehook-shaped device engagement element 40 into the lumen 48 of thedeployment tube. Further, the lumen of the deployment tube may also beof an oval cross-section throughout its length or may transition to acircular cross-section at a predetermined point along the length thereofas reflected in FIG. 4.

The cross-sectional view of FIG. 5 shows the deployment tube 18 insurrounding relationship to the first rod 38 of the deployment basemember 16. Here it can be seen how the T-shaped notch 52 on theretention limit member 50 engages the guide rail 42. Also visible in theview of FIG. 5 is the fact that the length of the deployment tube 18 isslightly less than the length of the first rod 38 such that thehook-shaped engagement element 40 extends outward from the distal end 46of the deployment tube.

In loading the incontinence device 14 into the deployment tube 18, thedevice comes packaged with the loop 25, fitted over the hook-shapedelement 40 in the space between the element 40 and the proximal end 46of the deployment tube. That is to say, the kit comes with the loop 26encircling the L-shaped hook element 40, thus obviating the need for theusers to touch the sterilized device 14. Now, when the finger grip 30 isgrasped between the thumb and foregoing of the user's one hand and thethumb and forefinger of the other hand are placed on the surfaces 54 ofthe deployment tube, the deployment tube may be slid in the distaldirection causing the retention loop to be drawn into the lumen 48 ofthe deployment tube as the retention limit 50 slides along the I-shapedguide rail 42 of the base member 16. The deployment tube is slid in thedistal direction until the retention limit member 50 comes into abutmentwith the stop member 44 on the rail 42, at which point only apredetermined portion of the retention loop 26 will extend out beyondthe distal end of the deployment tube 18, given the difference in lengthof the cylindrical rod 38 and the guide rail 42. The extending portionis still maintained rectilinear in that the remainder of the loop isstill constrained by the wall of the deployment tube. The describedincontinence device loading system also assures proper orientation ofthe loop as it expands upon entry into the bladder. With the aid of theL-shaped hook, the loop exits the lumen of the deployment tube in thesame orientation as it had upon entry into the proximal end of the tube.

Because the guide rail 42 has its upper flange notched, as at 56, whenthe retention limit member 50 reaches the stop 44, the guide tube withthe incontinence prevention device contained therein can be lifted freeof rail 42 of the deployment base member 16.

Next, the portion of the retention loop projecting outward from thedistal end of the deployment tube can be dipped into a sterilelubricating gel which may come with the kit and the user will nextinsert the distal end 58 of the plunger 20 (FIG. 6) into the lumen 48 atthe proximal end 46 thereof and will then insert the protruding portionof the retention loop into the urethral meatus until the insertion limitmember 50 is brought into contact with the subject's vestibule. Theinsertion limit member 50 is sufficiently large to prevent thedeployment tube from passing through the meatus. Now, by depressing thefinger rest 60 of the plunger 20, the incontinence prevention device isforced out from the deployment tube 18 and through the urethra until thefinger rest 60 of the plunger abuts the end 46 of the deployment tube asshown in FIG. 7. The length of the plunger is judiciously chosen suchthat when fully inserted, the retention loop will be disposed within thesubject urinary bladder where it can expand to its open loop shape fornesting in the bladder neck.

The deployment base member, deployment tube and pusher may be moldedfrom a suitable medical grade plastic, such as ABS, but limitation tothis material is not to be inferred.

FIG. 8 illustrates an alternative embodiment of the deployment device ofthe present invention. Here, the deployment base member includes only asingle longitudinally extending rod 70 that is affixed to and projectsfrom the finger grip member 72. Fitted over the rod 70 is a deploymenttube 74 that has a stop member 76 at a distal end thereof. The rod 70terminates in a hook 78 that extends outwardly beyond the distal end 80of the deployment tube 74 when the stop 76 is in abutment with the baseof the finger grip member 72. An incontinence prevention device of thetype already described is shown with its retention loop 26 looped overthe hook 78. The configuration shown in FIG. 8 would be packaged in asterile container with the hook 78 engaging the loop 26.

When removed by the user from the sterile package, she would grasp thefinger grip 72 between the thumb and forefinger of one hand and thedeployment tube 74 between the thumb and forefinger of the other handand then slide the deployment tube 74 to the right as shown in FIG. 8,drawing the retention loop 26 and the stem 14 into the deployment tube74. Instructions with the device would advise the user to uncouple thehook from the loop once a portion of the loop, approximately 15 mm inlength, is projecting from the distal end of the deployment tube. Asbefore, the projecting portion of the loop remains collapsed andrectilinear. It would be dipped in a lubricant and the deployment tubepositioned such that the lubricated tip of the retention loop isinserted into the urethral meatus and the stop 76 abuts the user'svestibule. A pusher, like that shown in FIG. 6, is again used to movethe incontinence prevention device out of the deployment tube andthrough the urethra until the retention loop 26 enters the urinarybladder and expands to its open loop configuration.

This invention has been described herein in considerable detail in orderto comply with the patent statutes and to provide those skilled in theart with the information needed to apply the novel principles and toconstruct and use such specialized components as are required. However,it is to be understood that the invention can be carried out byspecifically different equipment and devices, and that variousmodifications, both as to the equipment and operating procedures, can beaccomplished without departing from the scope of the invention itself.For example, a piece of string could be substituted for the deploymentbase member hook where the string loops through the retention loop ofthe incontinence prevention device and through the lumen of thedeployment tube. Immediately prior to deployment, by pulling on thestring, the incontinence prevention device will be drawn into andthrough the deployment tube with a portion of the retention loopextending beyond the end of the deployment tube as earlier described.

What is claimed is:
 1. A kit for use in treating female stressincontinence comprising: (a) an incontinence device having a relativelysoft, elastomeric shaft with a closed loop bladder retention structureat a distal end thereof; (b) a deployment base member having a fingergrip at a proximal end thereof, and first and second shafts projectinglongitudinally in parallel relation from the finger grip, the firstshaft including a hook element at a distal end thereof and the secondshaft having an abutment at a distal end thereof, the second shaft beinglonger than the first shaft by a predetermined amount; (c) a deploymenttube for receiving the incontinence device in a lumen thereof at a timeimmediately prior to deployment of the incontinence device into theurethra of a person, said deployment tube being slidable over the firstshaft for facilitating loading of the incontinence device into saidlumen; and (d) a plunger adapted to fit within said lumen for ejectingthe incontinence device form the deployment tube into the urethra. 2.The kit of either claim 1 or claim 1 and further including a sterilepackage for containing said incontinence device, said deployment basemember, said deployment tube and said plunger.
 3. The kit of eitherclaim 1 or claim 1 wherein said deployment base member, said deploymenttube and said plunger are molded from a medical grade plastic.
 4. Asterilized kit for use in treating female stress incontinencecomprising: (a) an incontinence device having a relatively soft,elastomeric shaft with a bladder retention means at a distal endthereon; (b) a deployment tube having first and second ends forreceiving the incontinence device in a lumen thereof; and (c) a pushermember insertable through said first end of the deployment tube forforcing the incontinence device out from the second end and though thesubject's urethra.
 5. A method for preparing an incontinence device forplacement in a female urethra comprising the steps of: (a) providing thekit of claim 1 with the closed loop encircling the hook element on thefirst rigid shaft and the deployment tube disposed around the firstrigid shaft; and (b) sliding the deployment tube off from the firstrigid shaft while gripping the finger grip such that the incontinencedevice is drawn into said lumen with a predetermined portion of theclosed loop bladder retention structure extending out beyond an end ofthe deployment tube.
 6. A method for inserting an incontinence device ina female's urethra comprising the steps of: (a) providing the kit ofclaim 4; (b) drawing the incontinence device into the first end of thedeployment tube, through the lumen so that a portion of the bladderretention means extending beyond the second end of the deployment tube;(c) positioning the second end of the deployment tube about the urethralmeatus; and (d) advancing the pusher member through the first end andthe lumen of the deployment tube to push the incontinence device up thefemale's urethra until the retention means is disposed in the female'surinary bladder.
 7. A sterilized kit for use in treating female urinarydysfunction comprising: (a) a deployment tube adapted for housing anddeploying a female intraurethral device, the deployment tube having anelement at a distal end thereof for preventing insertion of thedeployment tube through the urethral meatus.
 8. The sterilized kit ofclaim 7 and further including a pusher member insertable into a proximalend of the deployment tube for advancing the female urethral device upthe urethra of a female subject.
 9. The sterilized kit of claim 8 andfurther including a device for loading the female intraurethral deviceinto the deployment tube.